通用名称

efinaconazole

儿科标签批准日期

2020/4/26 0:00:00

特定指示/秒

Onychomycosis of the toenail in 6 years and older

标签更改摘要

- Safety and effectiveness were established in patients 6 years and older. - Use in these age groups is supported by evidence from well-controlled trials in adults with additional data from an open-label safety study in 60 pediatric patients 6 to 17 years (including a pharmacokinetic study in 17 patients 12 years to less than 17 years) - Safety and effectiveness in pediatric patients under 6 years have not been established. - Postmarketing study.

治疗类别

N/A

立法类型

PREA Only

产品说明书链接